The present invention relates generally to the field of orthopedic medicine and more specifically to the design of an improved medical bandaging product and material formed of a moisture-curable plastic material, a method for constructing such an improved medical bandage, and a method of constructing and applying an improved bandaging product.
Medical bandages for use in the treatment of injuries, such as broken bones requiring immobilization of a body member, are generally formed from a strip of fabric or scrim material impregnated with a substance which hardens into a rigid structure after the strip has been wrapped around the body member. The hardening substance traditionally used in carrying out this procedure is plaster-of-paris.
Conventional practice has been to fabricate a cast or splint upon an injured limb by initially applying to the limb a protective covering of a cotton fabric or the like and then overwrapping the covering and limb with a woven cloth impregnated with plaster-of-paris which has been wetted by dipping in water immediately prior to application. This practice is still in widespread use but possesses several significant disadvantages. For example, the above-described application procedure is messy and time consuming. Several components are required and considerable skill is necessary.
In order to alleviate the above-recited disadvantages of the conventional application procedure for plaster-of-paris casts and splints, unitary splinting materials have been devised and are disclosed in, for example, U.S. Pat. Nos. 3,900,024, 3,923,049, and 4,235,228. All of these patents describe a padding material with a plurality of layers of plaster-of-paris impregnated cloth. Such unitary splinting materials are not as messy and can be applied more quickly but still suffer from a number of disadvantages inherent in plaster-of-paris cast materials. All plaster-of-paris splints have a relatively low strength to weight ratio which results in a finished splint which is very heavy and bulky. Plaster-of-paris splints are slow to harden, requiring 24 to 72 hours to reach maximum strength. Since plaster-of-paris breaks down in water, bathing and showering are difficult. Even if wetting due to these causes can be avoided, perspiration over an extended period of time can break down the plaster-of-paris and create a significant problem with odor and itching.
A significant advance in the art of casting and splinting is disclosed in U.S. Pat. Nos. 4,411,262 and 4,502,479. The casting materials disclosed in these patents comprise a flexible fabric impregnated with a moisture-curing resin enclosed in a moisture-free, moisture-impervious package. Compared to plaster-of-paris, these products are extremely lightweight, have a very high strength to weight ratio and can be made relatively porous, permitting a flow of air through the casting material. Prior art moisture-curing systems include a package within which is contained a plurality of layers of fabric, such as fiberglass, impregnated with a moisture-curing resin. No provision is made for reclosing the package, so that the entire material must be very quickly used after removal from the package since such moisture-curing resins will cure in a relatively short period of time due merely to contact with atmospheric moisture.
U.S. Pat. Nos. 4,770,299 and 5,003,970, among others owned by applicant, each disclose roll-form synthetic bandaging products which include the ability to dispense desired lengths of bandaging material when needed, while sealing the remaining length of material for later use. These products have proven to be very successful in many applications, since they include a padding material on both sides, thereby permitting quick and easy application. Similar products are also sold in precut lengths sealed in a single use, moisture impervious envelope.
From the above discussion, it can be seen that both the conventional plaster-of-paris casting method and the more recent moisture-curable resin casting method possess both advantages and disadvantages. On the one hand, plaster-of-paris casts are bulky, heavy and difficult to apply whereas moisture-curable resin casts are lightweight, durable and relatively easy to apply. Plaster-of-paris can be very easily stored and used as needed since it has a relatively long shelf life so long as it is not completely wetted. On the other hand, the moisture-curable resins are very sensitive to the presence of even minute amounts of moisture which requires that either the materials be packaged in a wide variety of different shapes and sizes or unused portions be discarded, generating a substantial amount of waste and increasing the effective cost of the product.
Current padded, synthetic roll-form products are, however, relatively expensive and limit the option of the physician to use less padding or padding in different densities or thicknesses from one point on the splint to another.
This invention combines the advantages of both plaster-of-paris and moisture-curable resin systems while avoiding their respective disadvantages. This is accomplished by providing a unitary splinting system with improved strength and convenience. A unitary system is provided with the use of moisture-curing resin casting materials, together with a moisture-impervious package with means for resealing the package against entry of moisture after a desired length of bandaging product has been removed for use. In this manner, hardening of the bandaging product remaining in the moisture-impervious package is prevented thereby increasing the cost effectiveness of the system substantially. The product provides enhanced flexibility of use and reduced cost in comparison with other synthetic cast products by omitting the padding from the product, which may be then added by the technician during application of the splint or bandage.
It is therefore an object of the invention to provide an unpadded medical bandaging product in roll form with a moisture-curable resin which hardens the material upon exposure to moisture to form a rigid, self-supporting structure.
It is another object of the invention to provide an unpadded medical bandaging product which can be dispensed in any desired length while preventing hardening of the remaining material until use is desired.
It is another object of the invention to provide a unitary, unpadded medical bandaging product which includes a liner which can either be left on the substrate of the product or removed prior to application to the patient.
It is another object of the invention to provide a medical bandaging product which is less expensive that similar products with preapplied padding.
It is another object of the invention to provide a medical bandaging product which permits the technician applying the bandage to custom-apply and fit the padding to the substrate during application.
It is another object of the invention to provide a method of constructing a medical bandaging product which permits a wide variety of padding applications determined at the point of treatment.
These and other objects and advantages of the present invention are achieved in the preferred embodiment disclosed below by providing a medical bandaging product in roll form for being dispensed in predetermined lengths suitable for a given medical use, and comprising an elongate sleeve formed of moisture-impervious material and sealable to prevent entry of moisture, and an elongate medical bandage material substantially the same length as the sleeve and positioned in the sleeve in a single length along the length of the sleeve and sealed therein against entry of moisture until use. The medical bandage material comprises a substrate and a reactive system impregnated into or coated onto the substrate. The system remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self supporting structure. A protective liner sheet encloses the substrate along its length and forms a barrier between the substrate and the sleeve during storage, and is optionally removable after removal of the medical bandage material from the sleeve and prior to application to a patient. The substrate is adapted for having a protective padding material interposed between the substrate and the patient. Resealing means is provided for resealing the sleeve against entry of moisture after a predetermined length of the bandaging product has been dispensed for use to prevent hardening of the substrate remaining in the sleeve.
According to one preferred embodiment of the invention, the sleeve comprises an aluminum foil laminate having an outer tear resistant layer, a central aluminum foil layer and an inner heat sealable plastic layer.
According to another preferred embodiment of the invention, the substrate comprises a plurality of knitted or woven fabric layers.
According to yet another preferred embodiment of the invention, the protective liner sheet enclosing the substrate comprises a fibrous nonwoven material.
According to yet another preferred embodiment of the invention, the protective liner sheet enclosing the substrate comprises a nonwoven polypropylene sheet folded along its longitudinal axis to define an envelope within which the substrate is positioned.
According to yet another preferred embodiment of the invention, the reactive system comprises a blended polyisocyanate, polyol, catalyst and stabilizer.
According to yet another preferred embodiment of the invention, the resealing means for resealing the sleeve is selected from the group consisting of tape, a clamp, a clip for holding a folded end of the sleeve closed and a restricted opening through which the sleeve is extended.
According to yet another preferred embodiment of the invention, the roll comprises the sleeve with the medical bandage material therein and the sleeve formed into a coil.
Preferably, the invention includes a dispenser within which the coil of bandaging material is contained.
According to yet another preferred embodiment of the invention, the dispenser comprises a container within which the roll is positioned, the container defining a slot therein in which the leading end of the coil may be positioned and through which the product is dispensed as needed.
According to yet another preferred embodiment of the invention, a medical bandaging product is provided for being packaged in predetermined lengths suitable for a given medical use, and comprises a sleeve formed of moisture-impervious material and sealable to prevent entry of moisture and a medical bandage material positioned in the sleeve and sealed therein against entry of moisture until use. The medical bandage material comprises a substrate, a reactive system impregnated into or coated onto the substrate, the system remaining stable when maintained in substantially moisture-free conditions and hardening upon exposure to sufficient moisture to form a rigid, self supporting structure. A protective liner sheet encloses the substrate and forms a barrier between the substrate and the sleeve during storage and is optionally removable after removal of the medical bandage material from the sleeve and prior to application to a patient. The substrate is adapted for having a protective padding material interposed between the substrate and the patient.
According to yet another preferred embodiment of the invention, a medical bandaging product having a predetermined length suitable for a given medical use is provided, and comprises an enclosure formed of a moisture-impervious material sealable to prevent entry of moisture. The enclosure includes an elongate, resealable dispensing sleeve with a medical bandage material positioned in the enclosure and sealed therein against entry of moisture until use. The medical bandage material comprises a substrate formed of a plurality of knitted or woven fabric layers, a reactive system impregnated into or coated onto the substrate, the system remaining stable when maintained in substantially moisture-free conditions and hardening upon exposure to sufficient moisture to form a rigid, self supporting structure and comprising a blended polyisocyanate, polyol, catalyst and stabilizer. A soft, flexible protective nonwoven liner sheet encloses the substrate along its length and provides a barrier between the substrate and the sleeve within which the medical bandage material is enclosed. The liner sheet is adapted for being removed from the substrate after removal from the sleeve and prior to application to the patient. The medical bandage material is positioned in the enclosure for being dispensed in a desired use length from the sleeve. The sleeve is adapted for being resealed to prevent moisture from entering the enclosure.
An embodiment of the method of constructing a medical bandaging product according to the invention comprises the steps of providing an elongate, moisture-impervious sleeve and an elongate medical bandage material comprised of a substrate enclosed within a protective liner sheet, impregnating into or coating onto the substrate a reactive system which remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self-supporting structure, and positioning a length of the elongate medical bandage material within the elongate sleeve which is generally the same length as the sleeve and which extends along the length of the sleeve in a single layer. The sleeve is sealed to prevent entry of moisture until use.
According to one preferred embodiment of the method of the invention, the steps include providing a moisture impervious sleeve and a substrate for being enclosed within a protective liner sheet, and impregnating into or coating onto the substrate a reactive system which remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self-supporting structure. The coated or impregnated substrate is positioned within the protective liner sheet to form a medical bandage material. A length of the elongate medical bandage material is positioned within the elongate sleeve. The medical bandage material is generally the same length as the sleeve and extends along the length of the sleeve in a single layer. The sleeve is sealed to prevent entry of moisture until use.
According to one preferred embodiment of the invention, the method includes the step of rolling the elongate sleeve with the medical bandage material therein into a coil.
According to another preferred embodiment of the invention, the method includes the step of packaging the coil in a dispenser.
According to yet another preferred embodiment of the invention, the dispenser comprises a box provided with a slot therein for feeding a desired length of the sleeve therethrough.
A further embodiment of the method according to the invention comprises a method of utilizing a medical bandaging product, comprising the steps of providing an elongate sleeve and an elongate medical bandage material comprised of a substrate enclosed within a protective liner sheet, impregnating into or coating onto the substrate a reactive system which remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self-supporting structure, positioning the elongate medical bandage material within the elongate sleeve, and sealing the sleeve to prevent entry of moisture until use. The medical bandage material is removed from the sleeve immediately prior to use. The liner sheet is optionally removed from the substrate, and the substrate is wetted to activate the reactive system. A padding is interposed between the substrate and the patient. The substrate and interposed padding is applied to the patient.
According to one preferred embodiment of the invention, the step of interposing the padding between the patient and the substrate includes the step of applying the padding to the patient before the substrate is applied to the patient.
According to another preferred embodiment of the invention, the step of interposing the padding between the patient and the substrate includes the step of applying the padding to the substrate before application to the patient.
According to another preferred embodiment of the invention, the method includes the step of overwrapping the padding and substrate with an elastic bandage to maintain the padding and substrate in close conformity with the patient during curing of the moisture-curable resin.